114-009 1.4 VITESSE-COS ELCA

FDA registration

Sterigenics U.S., LLC·1 product·🇺🇸 United States

SELDINGER PERCUTANEOUS 2 PC NEEDLES

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOSPHERE SUTURE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

BONE SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

HEMO-SANITAS SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ETHYLENE OXIDE (EO)STERILIZATION EQUIPMENT

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Philips Laser System

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CVX-300 EXCIMER LASER SYSTEM

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ECLA GlideLight Catheter

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Philips Laser System

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ELCA CORONARY ATHERECTOMY CATHETERS

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ELCA Coronary Atherectomy Catheters

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ELCA CORONARY ATHERECTOMY CATHETERS

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM